Apiksaban Teva GmbH 5 mg filmom obložene tablete
| Name | Apiksaban Teva GmbH 5 mg filmom obložene tablete |
|---|---|
| Former Name | Apiksaban Teva 5 mg filmom obložene tablete; Apiksaban Pliva 5 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-741399572 |
| Active Substance | apiksaban |
| Composition | jedna filmom obložena tableta sadrži 5 mg apiksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska Actavis Limited, Zejtun, Malta |
| Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka |
| Marketing Authorisation Date | 14.01.2026 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/25-02/02 |
| Registration Number | 381-12-01/70-26-19 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B01AF02 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
